BioWorld5d
2025 the year device makers need to rework quality management system
Device makers doing business in the U.S. have had a much more stable regulatory regime than has been true for companies in other jurisdictions, but that will shift somewhat in 2025. Brynn Stanley of ...
US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP Compliance
In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device ...
drugdeliverybusiness8d
BD hit with FDA warning related to Pyxis medication management
The FDA has issued a warning letter related to BD Pyxis automated medication dispensing systems — technology that was part of ...
The New England Journal of Medicine11d
Innovative Approaches and Strategic Transformations in China’s Health Care System
The contents of the NEJM Catalyst–J-Med supplemental issue on care delivery in China capture the transformative strides in China’s health care system.
Yahoo Finance12d
BD receives FDA warning letter over quality system violations
BD received a warning letter after the Food and Drug Administration found fault with the practices at a facility that manufactures Pyxis medication management system medical ... that listed issues ...
Nasdaq13d
EBR Systems Advances Towards FDA Approval for WiSE® System
Inc., the creator of the innovative WiSE® CRT System for heart failure, has scheduled a crucial Pre-Approval Inspection with the FDA for early January 2025. This milestone is part of the ongoing ...
Nasdaq14d
Intelligent Bio Solutions Inc. Submits FDA 510(k) Application for Intelligent Fingerprinting Drug Screening System
premarket notification to the FDA for its Intelligent Fingerprinting Drug Screening System, a rapid and non-invasive drug testing method that analyzes sweat collected from fingertips. This ...
The American Journal of Managed Care14d
Top 5 Most-Read Articles From the Center on Health Equity & Access in 2024
Throughout 2024, the Center on Health Equity & Access explored critical gaps in health care access and innovative efforts to ...
BioSpace19d
Zimmer Biomet Receives FDA Clearance for OsseoFit™ Stemless Shoulder System for Total Shoulder Replacement
Dec. 13, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the ...
Care Quality Commission20d
Controlled drug accountable officers
Controlled drug accountable officers (CDAOs ... are governed by the Controlled Drugs (Supervision of Management and Use) Regulations 2013. be a senior manager of their organisation not routinely ...
Benzinga.com21d
European Biotech Pharming Group Touts Positive Data From Pivotal Pediatric Study Of FDA-Approved Immune System Disorder Drug
No serious drug-related adverse events reported; all 21 participants completed the trial with consistent improvements across doses. APDS is a genetic disorder that impairs the immune system.
FierceBiotech22d
FDA clears AngioDynamics’ NanoKnife pulsed field ablation system for prostate cancer
AngioDynamics has obtained an FDA green light for its NanoKnife prostate cancer ablation system, designed to precisely target and destroy tissue without delivering excess heat and the unintended ...